Investigation on the rapid determination of lactose content by polarimetry
10.19778/j.chp.2024.05.014
- VernacularTitle:旋光法快速测定乳糖含量的研究
- Author:
Haodong ZHAO
1
,
2
;
Xiaohua ZHOU
;
Xun ZHAO
;
Lin ZHU
;
Haiwei SHI
;
Qing HUANG
;
Yaozuo YUAN
Author Information
1. 江苏省食品药品监督检验研究院,南京 210019
2. 国家药品监督管理局化学药品杂质谱研究重点实验室,南京 210019
- Keywords:
lactose content;
rapid determination;
polarimetry;
comparability study;
quality control
- From:
Drug Standards of China
2024;25(5):512-516
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To established a rapid method for the determination of lactose(C12 H22 O11)content.Methods:The specific rotation([α]20D)of pure lactose was measured with lactose extract product,and the correc-tion coefficient was calculated.The measured rotatory value of the sample was multiplied by the correction coeffi-cient to obtain the mass(g)of lactose in the test product,and the lactose content was calculated.The equivalence of the newly established polarimetric method and the legal test method(HPLC-RID method)for the determination of lactose content was studied.Results:The linear relation of established method was excellent with the range of 0.05-0.20 g·mL-1(r=1.000 0)and the method also had good reproducibility(RSD=0.07％(n=6)).The lactose content of 141 batches samples measured by polarimetry was compared with the results determined by official analytical procedure,and the results showed the relative deviation between the same batches was less than 1.0％.The results of one-way ANOVA also showed that there was no significant difference between two groups(Sig.＞0.05).Conclusion:The performance of polarimetry is comparable to HPLC-RID in the Chinese Pharma-copoeia 2020 Vol Ⅳ.Meanwhile,the polarimetry can reduce the test cost,shorten the test time and meet the requirements of the quality control.
